During coronary procedure to treat a heavily calcified lesion in the mid left anterior descending (lad) vessel, four treatments on low speed and four treatments on high speed were performed in the left circumflex vessel using a diamondback 360 coronary orbital atherectomy device (oad).Following the last treatment, the driveshaft was observed to be fractured distal to the crown.The fractured fragment was successfully retrieved using a snare.The procedure was completed by intravascular lithotripsy (ivl) and stenting.The patient was admitted to the intensive care unit and is now discharged and in stable condition.
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The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.The device history record for this oad lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.Medwatch report: mw5153498.Csi id: (b)(4).
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